65/100 · Elevated
Manufactured by Amneal Pharmaceuticals NY LLC
Moderate Safety Concerns with Estradiol Transdermal
79,078 FDA adverse event reports analyzed
Last updated: 2026-05-12
ESTRADIOL TRANSDERMAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. Based on analysis of 79,078 FDA adverse event reports, ESTRADIOL TRANSDERMAL has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for ESTRADIOL TRANSDERMAL include DRUG INEFFECTIVE, NAUSEA, FATIGUE, HEADACHE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESTRADIOL TRANSDERMAL.
Estradiol Transdermal has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 79,078 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Ny Llc.
The most commonly reported adverse events include Drug Ineffective, Nausea, Fatigue. Of classified reports, 49.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include nausea, fatigue, and headache, indicating a broad range of mild to moderate side effects.
Serious adverse events, such as breast cancer and dizziness, are reported but at a lower frequency compared to non-serious events. There is a notable number of drug interaction reports, suggesting potential risks when combined with other medications. The majority of reports are from female patients, which aligns with the drug's intended use for hormone replacement therapy.
Patients taking Estradiol Transdermal should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions are a key safety signal, with 575 reports indicating potential risks when combined with other medications. Patients should consult healthcare providers before starting or stopping any other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Estradiol Transdermal received a safety concern score of 65/100 (elevated concern). This is based on a 49.8% serious event ratio across 41,509 classified reports. The score accounts for 79,078 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 38,052, Male: 724, Unknown: 86. The most frequently reported age groups are age 60 (829 reports), age 55 (825 reports), age 53 (806 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 41,509 classified reports for ESTRADIOL TRANSDERMAL:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Drug interactions are a key safety signal, with 575 reports indicating potential risks when combined with other medications. Patients should consult healthcare providers before starting or stopping any other medications.
If you are taking Estradiol Transdermal, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, fatigue, headache, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed usage instructions carefully to minimize the risk of adverse events. Report any unusual symptoms to your healthcare provider promptly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of estradiol transdermal patches, and regulatory actions may be taken based on ongoing data analysis.
The FDA has received approximately 79,078 adverse event reports associated with Estradiol Transdermal. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Estradiol Transdermal include Drug Ineffective, Nausea, Fatigue, Headache, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (3,429 reports), Nausea (2,577 reports), Fatigue (2,572 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Estradiol Transdermal.
Out of 41,509 classified reports, 20,666 (49.8%) were classified as serious and 20,843 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Estradiol Transdermal break down by patient sex as follows: Female: 38,052, Male: 724, Unknown: 86. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Estradiol Transdermal adverse events are: age 60: 829 reports, age 55: 825 reports, age 53: 806 reports, age 54: 780 reports, age 56: 759 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Estradiol Transdermal adverse event reports is Amneal Pharmaceuticals Ny Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Estradiol Transdermal include: Pain, Diarrhoea, Breast Cancer Female, Dizziness, Arthralgia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Estradiol Transdermal to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Estradiol Transdermal has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The most common reactions include nausea, fatigue, and headache, indicating a broad range of mild to moderate side effects.
Key safety signals identified in Estradiol Transdermal's adverse event data include: Breast cancer female (1708 reports). Dizziness (1544 reports). Drug interaction (575 reports). Product quality issue (638 reports). Product use issue (573 reports). These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions are a key safety signal, with 575 reports indicating potential risks when combined with other medications. Patients should consult healthcare providers before starting or stopping any other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Estradiol Transdermal.
Follow prescribed usage instructions carefully to minimize the risk of adverse events. Report any unusual symptoms to your healthcare provider promptly.
Estradiol Transdermal has 79,078 adverse event reports on file with the FDA. Serious adverse events, such as breast cancer and dizziness, are reported but at a lower frequency compared to non-serious events. The volume of reports for Estradiol Transdermal reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of estradiol transdermal patches, and regulatory actions may be taken based on ongoing data analysis. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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